Our Services

We specialize in devising strategies for reliable, reproducible, and high quality data collection

Quality  Chain of Custody  Flow Cytometry  Cytokine  Clinical

Services We Offer

Sample Processing and Cryopreservation

  • Processing of venous blood for isolation and cryopreservation of peripheral blood mononuclear cells (PBMCs)
  • Bone marrow aspirate processing and storage
  • TIL (Tumor Infiltrating Lymphocytes) processing, expansion and storage
  • Serum and Plasma processing and storage
  • Perform sample processing verification for all sites prior to study start
  • Contact HITS about their optimized processing techniques using different vacutainer tube types, which allow for a longer time prior to processing start

Epitope Discovery

  • Enzyme-Linked ImmunoSpot (ELISPOT) assay utilized in the identification of T cell epitopes

Multiparametric Flow Cytometry

  • Phenotypic characterization of cells or their activation, proliferation or antigen experience profile
  • Functional characterization of cells by Intracellular Cytokine Staining (ICS), CarboxyFluorescein Succinimidyl Ester (CFSE) staining or other proliferative assays, Killing assays, PhosphoFlow, Basophil activation test (BAT), Cell cycling, etc.

Serological Assays

  • Identification and quantification proteins and cytokines using MAGPIX Luminex assays

Study Design

  • Work with clients to cater documentation to assay needs, as well as regulatory requirements of pre-clinical and Phase I – III clinical studies
  • HITS can perform onsite training at study clinical sites to ensure consistent blood processing techniques across the entire study

Next Generation Sequencing

  • Certified SomaLogic service provider capable of targeted and custom sequencing of both DNA and RNA samples including T-Cell Receptor (TCR) and B-Cell Receptor (BCR) sequencing

Histology

  • Processing, embedding, sectioning and staining of formaldehyde-fixed and cryopreserved tissues using standard histological stains, immunohistochemical stains or custom developed stains

We offer a range of assays, and are able to design customized assays specifically tailored to address your research niche. All assay work is optimized and documented to meet client needs even when customized assays are used.

Overview of Assays

The core of HITS is a dedicated CytoFLEX LX flow cytometer equipped with a high-throughput sample loader and a Biomek NX robotic workstation.

Phenotypic Characterization

  • T cells, T regs, B cells, Monocytes, NK cells, ILCs, DCs, MDSCs
  • Immune-checkpoint receptors
  • Tetramer analyses

Functional and Proliferative Profiling

  • Intracellular Cytokine Stain (ICS), which is a measurement of CD4+ and CD8+ T cell immunity to common tumor antigens (i.e. HER-2, MUC1, NY-ESO-1, MAGE family, TERT)
  • Basophil Activation Test (BAT), which is based on mobilization of CD63, CD107a, CD203
  • CFSE dilution assay
  • Cell cycling
  • Phospho Flow cytometry
  • Killing assays

ELISPOT

  • Epitope Mapping
  • Functional profiling

Serological Assays

  • ELISA
  • MAGPIX Luminex, which is a multiplex analysis of plasma cytokines

FRET (Fluoresence Resonance Energy Transfer)

  • Protein interaction studies

T cell and B cell expansions

  • Enhance primary T or B cell lines by using feeder cells or specifically designed APCs

DNA and RNA Analyses

  • Microarray testing
  • Genotyping
  • Next Generation Sequencing
  • Bioinformatics Services

Histology

  • Processing/embedding
  • Sectioning
  • Routine staining
  • Specialized staining
  • Immunohistochemistry
  • Cryosectioning
  • Automated RNA In situ Hybridization using ACD RNAScope/Basescope Technology

Exclusive Equipment Onsite

  • CytoFLEX LX Flow Cytometer
  • Biomek NXp Automated Workstation
  • Micro-Analytical Balance XPE26
  • CTL Immunospot S6 FluoroCore Analyzer
  • Cellometer Auto 2000
  • MAGPIX
  • MVE1500 Liquid Nitrogen Freezer
  • Multiple freezers (-20°C, -80°C and LN2) and refrigerators (2-8°C) for all cold storage needs

Quality System

  • HITS internal Quality Assurance team is implementing quality systems, which adhere to the Good Clinical Laboratory Practices (GCLP) guidelines
  • Draft and implement Standard Operating Procedures (SOPs), Forms and Work Instructions (WIs) for general HITS use, and can be customized to clients’ requirements
  • Conduct routine internal audits
  • Equipment used for sample processing and assays are calibrated and maintained as per SOPs
  • Routinely monitor cold storage equipment temperatures and HITS facility room temperature/relative humidity
  • Chain of Custody protocols are in place to ensure trial samples are identified and traceable at all times
  • HITS maintains records from sample receipt to sample process to sample analysis
    • Includes documentation regarding collection, transportation, storage, processing and data analysis
    • HITS uses a cold storage inventory software to keep records of all samples stored
  • Sample and Data security is a priority for clinical trial samples and documentation

HITS Workflow for Clinical Trials

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